CD HORIZON® Fenestrated Screw Set 55750026540Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000148829), received between Oct 5, 2023 and Apr 16, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY FOR ADULT SPINAL DEFORMITY AND TH10-S2 LEVEL IMPLANT WAS PERFORMED. IT WAS REPORTED THAT THE SCREW LOOSENED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS PARTIAL REMOVAL WAS PERFORMED ON THE LEFT SIDE, TH10.11, L1.2 ADDITIONAL INFORMATION WAS RECEIVED ALL THE SCREWS WERE REMOVED FROM THE LEFT SIDE AND NO ADDITIONAL SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901731 ↗
• InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY FOR ADULT SPINAL DEFORMITY AND TH10-S2 LEVEL IMPLANT WAS PERFORMED. IT WAS REPORTED THAT THE SCREW LOOSENED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS PARTIAL REMOVAL WAS PERFORMED ON THE LEFT SIDE, TH10.11, L1.2 ADDITIONAL INFORMATION WAS RECEIVED ALL THE SCREWS WERE REMOVED FROM THE LEFT SIDE AND NO ADDITIONAL SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901714 ↗
• MalfunctionDec 16, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING TH12/L1/L2 TLIF TH11/L3 POSTERIOR SPINAL FUSION DUE TO OSTEOPOROTIC COMPRESSION FRACTURE. IT WAS REPORTED THAT POSTOPERATIVE CT REVEALED MEDIAL BREACH OF THE LEFT L2 SCREW AND CEMENT LEAKAGE INTO THE SPINAL CANAL. THE LEAKAGE IS CONSIDERED TO BE DUE TO THE SCREW DISLODGING INTO THE SPINAL CANAL. THE CEMENT LEAKAGE OCCURRED INTRAOPERATIVELY, AND IT WAS IDENTIFIED POSTOPERATIVELY. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE IS CURRENTLY NO PLAN TO EXPLANT THE SCREW. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Extravasation

  MAUDE report 23814512 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN SPINAL THERAPY FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT POST ARTHRODESIS THE ROD PLUG WAS OUT OF THE ROD AND SWIMMING IN THE BODY ON X-RAYS. THE PATIENT HAD HEADACHE AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE DEVICES. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: Headache

  MAUDE report 23053258 ↗
• InjuryAug 22, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSCUTANEOUS VERTEBRAL BODY FORMATION/TRANSCUTANEOUS POSTERIOR FUSION FOR OSTEOPOROTIC VERTEBRAL FRACTURE. IT WAS REPORTED THAT DURING CEMENT FI LLING OF THE CEMENT SCREW; CEMENT LEAKED TO THE SCREW HEAD. BECAUSE CEMENT LEAKED TO THE SCREW HEAD, THE CEMENT DELIVERY GUIDE TIP WAS RETAINED. THE PLANNED PERCUTANEOUS SURGERY ENDED UP NOT BEING ENTIRELY PERCUTANEOUS, RESULTING IN A SIGNIFICANTLY LARGER INCISION BEING MADE. THERE WAS A DELAY OF GREATER THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. A TOTAL OF 8 SCREWS WERE USED IN THE FIXED RANGE TH11/L3. ONLY THE RIGHT SIDE OF L2 LEAKED CEMENT ON THE SCREW HEAD SIDE. THE GUIDE TIP COULD BE REMOVED, BUT AFTER INSERTING THE ROD, THE SET SCREW COULD NOT BE INSERTED ON THE RIGHT SIDE OF L2. FOR THE RIGHT SIDE OF L2, THE SET SCREW INSTALLATION WAS ABANDONED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870449 ↗
• InjuryJul 10, 2025Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING TRANSCUTANEOUS POSTERIOR FIXATION USING A CEMENT SCREW WITH 2A-2B FOR DISH FRACTURE AND COMPRESSION FRACTURE AND TRANSCUTANEOUS VERTEBROPLASTY USING BKP AT LEVELS T9-L2. IT WAS REPORTED THAT POST SURGERY, THE CEMENT LEAKED INTO THE VEIN AND FLOWED INTO THE PULMONARY ARTERY. THIS WAS DISCOVERED AFTER THE PROCEDURE, AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF DISCOVERY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE MIXER HAD NO MALFUNCTION. REGARDING THE KITS AND SCREWS, THERE WAS A SMALL POSSIBILITY THAT THEY MAY HAVE CAUSED THE CEMENT LEAKAGE BUT THIS WAS NOT CONFIRMED. THERE WAS NO CHANGE IN THE PATIENT'S CONDITION AND NO ADDITIONAL TREATMENT OR PROCEDURE IS BEING PERFORMED AS A RESULT OF THIS EVENT. BUT THE PATIENT WAS FOUND TO HAVE STOMACH CANCER WHILE HE WAS IN THE HOSPITAL (WAITING FOR RECOVERY), AND THAT HE WOULD PERFORM A GASTRIC CANCER OPERATION WHICH WAS UNRELATED TO THIS EVENT. THEREFORE, IT IS UNKNOWN WHETHER HE HAS RECOVERED OR NOT. ADDITIONAL INFORM

  Patient problems: Pulmonary Embolism

  MAUDE report 22470297 ↗
• InjuryOct 5, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT BOTH S1 SCREWS (RIGHT AND LEFT) WERE BROKEN. THE PRODUCTS WERE EXPLANTED BUT THE TIPS REMAINED INSIDE THE PATIENT. IT WAS A REVISION CASE. THE PATIENT HAD PSEUDARTHROSIS AND A SCREW WAS IN THE CANAL FOR THIS REASON, THE PATIENT WAS OPERATED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17874956 ↗
• InjuryOct 5, 2023Break; Malposition of Device; Break; Malposition of Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT BOTH S1 SCREWS (RIGHT AND LEFT) WERE BROKEN. THE PRODUCTS WERE EXPLANTED BUT THE TIPS REMAINED INSIDE THE PATIENT. IT WAS A REVISION CASE. THE PATIENT HAD PSEUDARTHROSIS AND A SCREW WAS IN THE CANAL FOR THIS REASON, THE PATIENT WAS OPERATED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17874906 ↗